Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Universidad Europea de Madrid
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.
Detailed Description
After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry. The clinical trial will include a control group (waiting list). Patients who meet eligibility requirements will be assigned to control group or intervention group. Psychological intervention will consist in an 8-session individual face-to-face delivered ACT-based treatment. The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic kidney disease on haemodialysis
- •Older than 18 years-old
- •At least 3 months on haemodialysis
- •HADS Global Scale Score ≥14
Exclusion Criteria
- •Diagnosis of severe or chronic mental disorder, mental retardation and cognitive impairment, or disabling illness.
- •Antidepressant drugs consume
- •Insufficient understanding of Spanish.
- •Patients who are in the Advanced Chronic Kidney Disease Unit
- •Receiving other psychological treatment
Outcomes
Primary Outcomes
Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from Baseline Emotional Distress at 5 months
HADS assesses anxiety, depression and emotional distress. It is a 14-item four-point Likert-type scale. Scores range between 0 and 42. Higher the score in the overall score indicate higher levels of emotional distress and worse outcome.
Secondary Outcomes
- Change in Simplified Medication Adherence Questionnaire (SMAQ)(Change from Baseline Adherence at 5 months)
- Change in COOP/WONCA questionnaire(Change from Baseline health related Quality of Life at 5 months)
- Change in mood assessed through Daylio App(Change from Baseline mood at 5 months)
- Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)(Change from Baseline psychological inflexibility at 5 months)
- Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)(Change from Baseline coping strategies at 5 months)